Class II

Drug Recall: DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

Direct Rx · June 22, 2026

Reason for Recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Distribution

U.S. Nationwide

States Affected

NATIONWIDE

Quantity Affected

263 Bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0617-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Direct Rx Drug Recall: DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx. | SafeCheck